HealthyANTERO-3NCT03664570
Enteral Nutrition Infusion Rate and Gastric Function
A study testing VIPUN Balloon Catheter in people with Healthy, run by Prof Dr Jan Tack at 1 site in Belgium.
Trial summary
A complex neurohumoral feedback mechanism regulates gastric emptying of enteral nutrition through changes in gastric motility. In this investigation, we aim to investigate the impact of different infusion rates of enteral nutrition on gastric motility, gastric emptying rate, epigastric symptoms and satiation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- VIPUN Balloon Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Oct 2018to 5 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- At least 18 years old
- BMI between and including 18 and 30
- Understand and able to read Dutch
- In good health on the basis of medical history
- Female subjects of childbearing potential are willing to use adequate contraception
- Refrains from herbal, vitamin and other dietary supplements on the day of the visits
Who cannot join
- Dyspeptic symptoms (assessed with PAGI-SYM questionnaire)
- Using any medication that might affect gastric function or visceral sensitivity
- Known / suspected current use of illicit drugs
- Known psychiatric or neurological illness
- Any gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator
- History of heart or vascular diseases like irregular heartbeats, angina or heart attack
Show all 16Show fewer
- Nasopharyngeal surgery in the last 30 days
- History of thermal or chemical injury to upper respiratory tract or esophagus
- Current esophageal or nasopharyngeal obstruction
- Known coagulopathy
- Known esophageal varices
- Metal or other MRI incompatible implants
- Contra-indications for MR (checked by MR safety questionnaire)
- Pregnancy
- Claustrophobia
- Have a known allergy or intolerance to cow milk, soy, saccharose or any other ingredient of Isosource Standard.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ANTERO-3: The Impact of Enteral Nutrition Infusion Rate on Gastric Motility and Gastric Emptying Rate, Measured With the VIPUN Balloon Catheter, Magnetic Resonance Imaging and the 13C-octanoate Breath Test.
A complex neurohumoral feedback mechanism regulates gastric emptying of enteral nutrition through changes in gastric motility. In this investigation, we aim to investigate the impact of different infusion rates of enteral nutrition on gastric motility, gastric emptying rate, epigastric symptoms and satiation.
Additionally, magnetic resonance imaging will be used to validate an extended 13C-octanoate breath test for gastric emptying of a liquid test meal that is infused over 2 hours. Furthermore, the reliability of a manual position check of the VIPUN Balloon catheter will be confirmed with radiographic imaging. Finally, the data will be used for the data driven optimization of the VIPUN MI algorithm.
- Conditions
- Healthy
- Being tested
- VIPUN Balloon Catheter
- Keywords
- Gastric motility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIPUN Balloon CatheterDevice
Also called VIPUN system
The VIPUN Balloon Catheter is a nasogastric balloon catheter consisting of a standard nasogastric double lumen Sump catheter and a balloon attached to this catheter. Once the catheter is advanced into the stomach, the balloon can be inflated. The inflated balloon dimensions and intraballoon pressure are such that intragastric motility can optimally be assessed without inducing epigastric symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Condition A | Experimental | * Infusion rate = 25 ml/h
* Radiography: confirmation balloon position
* VIPUN Balloon Catheter
* 13C-Octanoate Breath Test o Receives: Device: VIPUN Balloon Catheter |
| Condition B | Experimental | * Infusion rate = 75 ml/h
* Magnetic resonance imaging
* VIPUN Balloon Catheter
* 13C-Octanoate Breath Test Receives: Device: VIPUN Balloon Catheter |
| Condition C | Experimental | * Infusion rate = 250 ml/h
* Magnetic resonance imaging
* VIPUN Balloon Catheter
* 13C-Octanoate Breath Testt Receives: Device: VIPUN Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motility
Motility index (MI) measured with the VIPUN Balloon Catheter.
Measured: 8 hour
Gastric emptying rate (13C-Octanoate Breath Test)
Gastric emptying rate of liquid test meal, measured with 13C-Octanoate Breath Test.
Measured: 8 hour
Gastric emptying rate (Magnetic resonance imaging)
Gastric emptying rate of liquid test meal, measured with magnetic resonance imaging
Measured: Conditions B and C: 4 hour.
Secondary outcomes (6)
Satiation
Subjective satiation score at a 30-minute interval. Visual Analogue Scale (100 mm, 0=absent, 100= maximal sensation).
Measured: 6 hour
Safety profile VIPUN Balloon Catheter
Incidence, frequency, severity, seriousness and relatedness of AE's
Measured: Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks
Feasibility VIPUN Balloon Catheter related procedures
Success rate of completing the procedure (placement and removal VIPUN Balloon Catheter
Measured: Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks
Reliability manual position check
Success rate (pass/fail) (reliability) of the manual position check of the VIPUN balloon catheter
Measured: Once for each subject (during Condition A only): Position of the inflated balloon is judged on the thorax Rx (t<0) prior to start motility recording (= reference time point, t=0).
Position catheter at t=480.
Qualitative assessment of the migration of the catheter over the course of the study procedures.
Measured: During Condition A only: at t=480 minutes (after cessation motility recording).
Epigastric symptoms
Subjective epigastric symptom scores at a 30-minute interval. 3 Visual Analogue Scales (100 mm, 0=absent, 100= maximal sensation). Scale 1: Nausea, Scale 2: Bloating, Scale 3: Pain.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start3 Oct 2018
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three-way crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof Dr Jan Tack
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof Dr Jan Tack, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664570
- Sponsor's protocol ID
- S61853
- Acronym
- ANTERO-3
- Status last verified
- Apr 2019
- First submitted
- 29 Aug 2018
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANTERO-3: The Impact of Enteral Nutrition Infusion Rate on Gastric Motility and Gastric Emptying Rate, Measured With the VIPUN Balloon Catheter, Magnetic Resonance Imaging and the 13C-octanoate Breath Test.
- ClinicalTrials.gov ID
- NCT03664570
- Acronym / sponsor ID
- ANTERO-3 / S61853
- Conditions
- Healthy
- Keywords
- Gastric motility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Prof Dr Jan TackUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A complex neurohumoral feedback mechanism regulates gastric emptying of enteral nutrition through changes in gastric motility. In this investigation, we aim to investigate the impact of different infusion rates of enteral nutrition on gastric motility, gastric emptying rate, epigastric symptoms and satiation.
Additionally, magnetic resonance imaging will be used to validate an extended 13C-octanoate breath test for gastric emptying of a liquid test meal that is infused over 2 hours. Furthermore, the reliability of a manual position check of the VIPUN Balloon catheter will be confirmed with radiographic imaging. Finally, the data will be used for the data driven optimization of the VIPUN MI algorithm.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-way crossover
| Arm | Type | Receives |
|---|---|---|
| Condition A | Experimental | Device: VIPUN Balloon Catheter* Infusion rate = 25 ml/h * Radiography: confirmation balloon position * VIPUN Balloon Catheter * 13C-Octanoate Breath Test o |
| Condition B | Experimental | Device: VIPUN Balloon Catheter* Infusion rate = 75 ml/h * Magnetic resonance imaging * VIPUN Balloon Catheter * 13C-Octanoate Breath Test |
| Condition C | Experimental | Device: VIPUN Balloon Catheter* Infusion rate = 250 ml/h * Magnetic resonance imaging * VIPUN Balloon Catheter * 13C-Octanoate Breath Testt |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed Informed Consent
- At least 18 years old
- BMI between and including 18 and 30
- Understand and able to read Dutch
- In good health on the basis of medical history
Key exclusion criteria (16 listed)
- Dyspeptic symptoms (assessed with PAGI-SYM questionnaire)
- Using any medication that might affect gastric function or visceral sensitivity
- Known / suspected current use of illicit drugs
- Known psychiatric or neurological illness
- Any gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIPUN Balloon CatheterAlso: VIPUN systemThe VIPUN Balloon Catheter is a nasogastric balloon catheter consisting of a standard nasogastric double lumen Sump catheter and a balloon attached to this catheter. Once the catheter is advanced into the stomach, the balloon can be inflated. The inflated balloon dimensions and intraballoon pressure are such that intragastric motility can optimally be assessed without inducing epigastric symptoms. | Device | Condition A, Condition B, Condition C |
Primary outcome
Motility
Time frame: 8 hour
Motility index (MI) measured with the VIPUN Balloon Catheter.
Gastric emptying rate (13C-Octanoate Breath Test)
Time frame: 8 hour
Gastric emptying rate of liquid test meal, measured with 13C-Octanoate Breath Test.
Gastric emptying rate (Magnetic resonance imaging)
Time frame: Conditions B and C: 4 hour.
Gastric emptying rate of liquid test meal, measured with magnetic resonance imaging
6 secondary outcomes
Satiation
Time frame: 6 hour
Safety profile VIPUN Balloon Catheter
Time frame: Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks
Feasibility VIPUN Balloon Catheter related procedures
Time frame: Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks
Reliability manual position check
Time frame: Once for each subject (during Condition A only): Position of the inflated balloon is judged on the thorax Rx (t<0) prior to start motility recording (= reference time point, t=0).
Position catheter at t=480.
Time frame: During Condition A only: at t=480 minutes (after cessation motility recording).
Epigastric symptoms
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIPUN Balloon Catheter in people with Healthy, run by Prof Dr Jan Tack at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motility (time frame: 8 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.